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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05427578
Other study ID # HSEARS20210323001-01
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date August 1, 2021
Est. completion date February 29, 2024

Study information

Verified date September 2023
Source The Hong Kong Polytechnic University
Contact Georg S Kranz, PhD
Phone 2766
Email georg.kranz@polyu.edu.hk
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Functional near infrared spectroscopy (fNIRS) offers a cheap and reliable tool to investigate prefrontal brain activation in the healthy and diseased human brain. As such, fNIRS bears great potential as a diagnostic tool for clinical practice. Research indicates that fNIRS, together with a relatively simple task to activate the prefrontal cortex, the so-called verbal fluency task (VFT), elucidates prefrontal dysfunction in major depressive disorder (MDD). This finding can potentially serve as an imaging marker for disease pathology, even when depressive symptoms are absent. Indeed, recent research also suggests prefrontal dysfunction in fully remitted MDD (rMDD). Prefrontal haemodynamic responses may therefore serve as a trait marker for MDD vulnerability. This study aims to investigate the haemodynamic response in rMDD, healthy participants with increased MDD risk (HCr; having a 1st-degree relative with MDD), and low-risk healthy participants (HCnr; having no 1st-degree relatives with MDD) using fNIRS. The investigators hypothesize lower prefrontal reactivity in HCr compared to HCnr, and lowest prefrontal reactivity in rMDD compared to HCnr. This study has the potential to elucidate the neuronal underpinnings of depression vulnerability in the absence of symptoms that are sometimes considered a confounding factor when it comes to studying the biological encoding of depression.


Description:

Healthy participants with a high risk of MDD (HCr), healthy participants with a low risk of MDD (HCnr) and rMDD participants will be included in this study. Prefrontal haemodynamic response will be measured in all participants during the verbal fluency test (VFT) using 52 channels fNIRS. The VFT involves two neural conditions, one positive condition, and one negative condition. Both the neuroimage change and the behavioral outcomes of VFT will be compared within-group and among groups. The correlation between the neuroimage change and the behavioral outcomes will be analyzed as well.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date February 29, 2024
Est. primary completion date February 29, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 35 Years
Eligibility Inclusion Criteria: - Mini-mental state examination (MMSE) > 24 Exclusion Criteria: - Current diagnosis of psychiatric disorders, such as depression, anxiety, schizophrenia, or autism - current or past diagnosis of neurological disorders, such as head injuries, strokes, encephalitis, epilepsy, Parkinson's, or Alzheimer's

Study Design


Related Conditions & MeSH terms


Intervention

Other:
fNIRS measurement
measurement using functional near-infrared spectroscopy

Locations

Country Name City State
Hong Kong The Hong Kong Polytechnic University Hong Kong

Sponsors (1)

Lead Sponsor Collaborator
Dr Georg Kranz

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type Measure Description Time frame Safety issue
Primary Oxygenated hemoglobin (HbO) change during VFT The HbO change during VFT measuring by fNIRS Up to 6 months
Secondary Deoxygenated hemoglobin (HbR) change during VFT The HbR change during VFT measuring by fNIRS Up to 6 months
Secondary The VFT outcome The number of correct words during VFT Up to 6 months
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